Combination of baricitinib and adalimumab vs. baricitinib alone in patients with rheumatoid arthritis

Phase 1

Active, not recruiting

• Conditions: Therapeutic area: Body processes [G] - Immune system processes [G12]; rheumatoid arthritis (RA)

• Registration Number: EUCTR2020-004345-37-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-11
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male or female;
- Age between 18 and 75 years-old;
- Adult patient with a diagnosis of RA as defined by the ACR/EULAR 2010 criteria for the classification of RA;
- Patient who presents an inadequate response to one to four bDMARDs or tsDMARDs for at least 12 weeks prior to study entry at a dose that is considered acceptable to assess clinical response adequately;
- Patient affected by active RA (DAS28-ESR > 3.2) eligible to receive a bDMARD or tsDMARD according to the French Society of Rheumatology guidelines;
- Patient treated by prednisone dosage = 10mg per day. The corticosteroids dosage will be decreased to 7,5 mg/day at the beginning of the study (W0);
- Person affiliated with or beneficiary of the French social security scheme;
- Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any examination required by the research project).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

- Patient previously treated with baricitinib or adalimumab for RA;
- Patient affected by another form of inflammatory arthritis with the exception of secondary Sjögren syndrome;
- Patient who presents contraindications to the study treatments;
- Patient who is currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or has been receiving an unstable dosing regimen of corticosteroids within 4 weeks of study entry;
- Patient who is currently receiving more than 1 concomitant csDMARD (MTX, leflunomide, hydroxychloroquine or sulfasalazine) at the time of study entry;
- Patient who is currently receiving or has received csDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX (up to 25 mg/week), leflunomide (up to 20 mg/day), hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry.
- Patient who has received any parenteral corticosteroid administered by intramuscular or intravenous injection within 4 weeks prior to study entry, or is anticipated to require parenteral injection of corticosteroids during the study;
- Patient who had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 4 weeks prior to study entry. Joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization cannot be counted in the TJC and SJC for entry or enrollment purposes;
- Patient with haemoglobin less than 80 g/L, absolute lymphocyte count lower than 0.5×109/L, absolute neutrophil count less than 1×109/L, or platelet count less than 100×109/L; clearance creatinine less than 60 mL/min; total bilirubin more than 1,5 times the upper limit of normal (ULN) at screening, aspartate aminotransferase, or alanine amino-transferase more than 2 times the upper limit of normal (ULN) at screening.
- Patient with co-administration with OAT3 inhibitors with a strong inhibition potential (such as probenecid);
- Patient who has a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data;
- Patient who has a history of VTE (DVT/PE) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). Prior DVT with PE where events overlapped in time (i.e., with PE considered resulting from DVT) is not considered recurrent DVT/PE for the purpose of this criterion;
- Patient who has been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination). Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with nonlive vaccines intended to prevent infectious disease prior to entering patients into the study;
- Patient with an active cancer;
- Patient with malignancy or history of malignancy in the past 5 years, with the exception of adequately treated or excised non-metastatic basal-cell or squamous-cell cancer of the skin or cervical carcinoma in situ;
- Patient who has a current or recent (<30 days prior to study entry) clin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified